BCMA-CD19 CAR-T Cell Therapy for Relapsed Multiple Myeloma with Extramedullary Infiltration
Dual-targeting BCMA-CD19 CAR-T cell infusion
Blood Protein Disorders+16
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: May 25, 2025
Actual date on which the first participant was enrolled.This clinical trial focuses on a new treatment for people with relapsed or difficult-to-treat multiple myeloma that has spread outside the bone marrow. The study aims to test a special therapy called BCMA-CD19 CAR-T cell therapy, which targets specific proteins on cancer cells. By doing so, the therapy hopes to improve treatment outcomes for these patients whose conditions are hard to manage with existing treatments. This research is crucial because it addresses a significant challenge in treating this type of cancer, offering hope for better management of the disease. Participants in the study will receive the BCMA-CD19 CAR-T cell therapy through an infusion. The study will closely monitor the safety of this treatment by tracking any side effects or toxic reactions within the first month after the infusion. Researchers will pay particular attention to detecting any serious side effects that may limit the dosage patients can safely receive. By analyzing the type and frequency of these reactions, the study aims to ensure the treatment is both safe and effective for future use. The trial plans to involve up to 18 participants to gather sufficient data on the treatment's safety profile.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Voluntarily participate in the trial and have good compliance. 2. Aged between 18 and 75 years old, regardless of gender. 3. Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma. 4. Positive for BCMA in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue. 5. Organ functions: ① Cardiac function: Left ventricular ejection fraction \> 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine aminotransferase and aspartate aminotransferase \< 3 times the upper limit of normal (ULN). ③ Renal function: Creatinine clearance rate ≥ 40 mL/min (by Cockcroft and Gault formula). ④ Coagulation function: PT and APPT \< 1.5 times the ULN. ⑤ Arterial oxygen saturation (SpO₂) \> 95%. ⑥ Pulmonary function: FEV₁% predicted value ≥ 50%. 6. Female patients of childbearing age must have a negative serum pregnancy test at screening and before receiving cyclophosphamide and fludarabine or melphalan treatment; male patients should be willing to use effective contraceptive methods for 1 year after receiving the study treatment. 7. ECOG score ≤ 2. 8. Expected survival time \> 3 months. Exclusion Criteria: 1. Pregnant or lactating women. 2. Active infections that have not been effectively controlled. 3. Active autoimmune diseases that have not been effectively controlled. 4. Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1. 5. For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled. 6. Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA copy number above the lower limit of measurability; positive anti - Treponema pallidum antibody (TP - Ab); positive human immunodeficiency virus (HIV) antibody test. 7. Allergic or intolerant to fludarabine or cyclophosphamide. 8. Suffering from known symptomatic non - plasma cell infiltrative central nervous system diseases. 9. Uncontrollable cardiovascular and cerebrovascular diseases within 6 months, such as: a. New York Heart Association (NYHA) class III or IV congestive heart failure. b. Myocardial infarction occurred or coronary artery bypass grafting (CABG) was received ≤ 6 months before enrollment. c. Clinically significant ventricular arrhythmia or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration). d. A history of severe non - ischemic cardiomyopathy. 10. A history of other untreated malignancies within the past 5 years or having other untreated malignancies concurrently. 11. The investigator assesses that the subject cannot or is unwilling to comply with the requirements of the study protocol. 12. Previous use of a CAR - T vector with the same structure.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location